Envoy Medical Reaches Enrollment Milestone in Pivotal Clinical Study of Fully Implanted Acclaim(R) Cochlear Implant

About this update from Envoy Medical, Inc.

[{"type":"text","content":"Enrollment momentum accelerates as Company advances toward full enrollment","length":74,"tagName":"p","attribs":{"class":"nfSubHeading"},"className":""},{"type":"text","content":"White Bear Lake, Minnesota--(Newsfile Corp. - December 18, 2025) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced that its pivotal clinical study for the investigational fully implanted Acclaim® cochlear implant has achieved yet another milestone by reaching the midway point of the study's full enrollment target.","length":449,"tagName":"p"},{"type":"text","content":"Despite holiday scheduling and year-end operating room constraints, enrollment is progressing at a steady pace. Sites report actively screening numerous potential candidates. Full enrollment is currently on track to be completed within the first half of Q1 2026.","length":262,"tagName":"p"},{"type":"text","content":""Reaching the midway point of the study's enrollment is another strong indication that our pivotal study continues to move forward efficiently," said Brent Lucas, Chief Executive Officer of Envoy Medical. "Even in a season that traditionally makes scheduling difficult, the investigational sites and our internal teams are performing exceptionally well."","length":378,"tagName":"p"},{"type":"text","content":"The investigational fully implanted Acclaim® cochlear implant is designed to leverage the natural ear, rather than an external microphone, to capture sound using the Company's proprietary implanted piezoelectric sensor.","length":223,"tagName":"p"},{"type":"text","content":"Lucas added, "We believe our fully implanted approach represents the future of hearing implants. The momentum in our pivotal study and the enthusiasm we are seeing from professionals in the field underscore the strong differentiation of our technology and our leadership as the industry shifts toward fully implanted solutions."","length":338,"tagName":"p"},{"type":"text","content":"The Acclaim cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a U.S. based pivotal clinical trial. For more information on the trial, visit www.envoymedical.com/acclaim-pivotal.","leng...

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